Job Summary

The Sr. Director Operations leads the development, implementation, and adherence to all GMP procedures and policies related to Production. The Sr. Director has oversight of Materials Management, MS&T and Manufacturing and is responsible for planning, coordinating, and scheduling of client processes and programs. The Sr, Director champions a progressive culture of continuous improvement and leads their respective teams by example and influence. The role has overall responsibility for developing a culture to support client programs with internal and external partners to provide phase appropriate development strategies which meet the rigor and interpretation of regulatory authorities.

Key Responsibilities and Duties:

• Serve as the subject matter expert in the areas of Material planning, production, and technology transfer from Process Development to Production.
• Day to day management of large teams and oversight for right the first-time execution and timely delivery of client product.
• Establish, direct, and monitor implementation of appropriate CMC development methodology and specifications for intermediates, active pharmaceutical ingredients (APIs) and drug products (DPs)
• Partner with cross-functional teams to drive on time delivery and quality standards.
• Support of organizational development and cultural leadership.
• Create a positive motivated team-centric environment that attracts, retains, and develops the top talent.
• Work closely with external CRO/CDMO collaborators to meet strategic company goals and business plan.
• Provide detailed review and approval for protocols, reports, and raw data for production functions.
• Identify, evaluate, select, and develop relationships while actively managing external parties (CROs, CMOs, CMC clients, Government agencies, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts.
• Participates as CMC subject matter expert in quality audits.
• Establish credibility as an SME for all production issues inside and outside the organization.
• Work closely with QA,QC, Process Development and BD departments to ensure project timelines are met.
• Coach and mentor, the internal scientific teams engaged in analytical support, to facilitate product candidate molecule development.
• Other responsibilities as needed
  

Job Qualifications

• Extensive experience in Viral Vector Production including Lentivirus and AAV.
• Experience with large molecule analytical/physicochemical testing strategies and characterization of complex vectors \Experience in leading Regulatory audits and commercial operations.
• Strong communication skills, with the ability to build strong relationships with key individuals at CMC suppliers and interact effectively in multidisciplinary teams both internally and externally.
• M.S. in Biology or related field
• 10+ years in operations management/leadership experience in a cGMP environment, with a specific focus on virology.
• Extensive review and auditing experience in production methodologies
• Working knowledge of viral vector and/or vaccine development
• Knowledge of ICH/USP/EP/JP guidelines as it relates to Manufacturing Development
• Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies
• Technical understanding of lot release test methods
• Excellent verbal and written communication skills
• Working knowledge of Quality Systems (QS) such as Training, Deviation Management, CAPA, Supplier Management, and Documentation Control, and the applicability of quality systems to the Analytical operations
  

Compensation Data

The pay range for this position is $180,000 to $220,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.